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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Children scheduled for clinically indicated right heart catheterization were screened for enrollment. Participants were enrolled at 16 centers in the United States, United Kingdom, France, Spain and Netherlands.

Study duration was 2 years (primary) with 1 and 3 year follow-ups.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

One hundred thirty six participants were enrolled (intent-to-treat population). One hundred twenty-one participants completed the study. Participants served as their own controls and received all 3 treatments.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Limitations of the study, such as early termination leading to small numbers of participants
analyzed and technical problems with measurement leading to unreliable or uninterpretable data

Although the first and last treatments were randomly assigned, the second treatment was always the iNO/O2 combination. Without randomization of all 3 treatments, we cannot exclude an interaction of time with treatment.

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.